Breath Ammonia as a Malnutrition Screening Tool

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. Breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. Some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: t
View:

• Age: 18-95 years

• Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Contact Information
Primary
Jacob T Mey, PhD, RD
jacob.mey@pbrc.edu
225-763-2644
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 12
Treatments
Experimental: Feeding
Participants will be instructed to consume study beverages to provide \>1.2 grams of protein per kilogram bodyweight and \>120% of total energy needs. Energy needs will be estimated by the Mifflin-St Jeor equation multiplied by an activity factor of 1.5. Study beverages will be a mix of meal replacement shakes e.g., Ensure (Abbott Laboratories, Chicago, IL, USA) products to accommodate protein and energy needs. Study beverages will be consumed every \~3 hours to induce a perpetually fed state. Feeding will occur during waking hours, typically between 7a-11p. Breath will be collected before, during and after the intervention.
Experimental: Fasting
Participants will be instructed to consume only water during the duration of the Fasting Protocol. Regardless of the randomization sequence, participants will have consumed their last meal or study beverage by 11p the night prior. Breath will be collected before, during and after the intervention.
Related Therapeutic Areas
Sponsors
Leads: Pennington Biomedical Research Center

This content was sourced from clinicaltrials.gov